KaiBiLi Extended ViralTrans Saline

Basic Information

• Brand Name: KaiBiLi Extended ViralTrans Saline
• Primary DI: 16972698600552
• Version / Model: M221128
• Company Name: Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
• Labeler DUNS: 547938709
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-12-19
• Public Version: 2
• Public Version Date: 2024-02-08
• Public Version Status: Update
• Public Device Record Key: c38c343f-1ece-42a2-b157-cf10b9bfda45

Device Description

5 mL with regular flocked swab and minitip flocked swab

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	866.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65196	General specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26972698600559	GS1		8	In Commercial Distribution
Primary	16972698600552	GS1
Unit of Use	06972698600555	GS1